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Expert Opinion on Pharmacotherapy Volume 3, 2002 - Issue 6
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Review

Levothyroxine: therapeutic use and regulatory issues related to bioequivalence

Leonard Wartofsky Department of Medicine, Washington Hospital Center, 110 Irving Street, NW, Washington, DC 20010-2975, USA. [email protected]
Pages 727-732 | Published online: 25 Feb 2005

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Camilla Hauge, Astrid Breitschaft, Marie-Louise Hartoft-Nielsen, Simon Jensen & Tine A. Bækdal. (2021) Effect of oral semaglutide on the pharmacokinetics of thyroxine after dosing of levothyroxine and the influence of co-administered tablets on the pharmacokinetics of oral semaglutide in healthy subjects: an open-label, one-sequence crossover, single-center, multiple-dose, two-part trial. Expert Opinion on Drug Metabolism & Toxicology 17:9, pages 1139-1148.
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Nikhil Khandelwal, Beverly Johns, Zsolt Hepp & Jane Castelli-Haley. (2018) The economic impact of switching from Synthroid for the treatment of hypothyroidism. Journal of Medical Economics 21:5, pages 518-524.
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Articles from other publishers (27)

James Akingbasote, Sandra Szlapinski, Elora Hilmas, Patrik Miller & Natalie Rine. 2022. Recent Advances in Therapeutic Drug Monitoring and Clinical Toxicology. Recent Advances in Therapeutic Drug Monitoring and Clinical Toxicology 197 232 .
Sherif Monib, Hany Habashy & Mohamed Ibrahim. (2021) Thyroid autotransplantation after total thyroidectomy in multi-nodular goiter—a case series analysis. Indian Journal of Surgery 83:6, pages 1451-1456.
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Carmil Azran, Nirvana Hanhan-Shamshoum, Tujan Irshied, Tomer Ben-Shushan, Dror Dicker, Arik Dahan & Ilan Matok. (2021) Hypothyroidism and levothyroxine therapy following bariatric surgery: a systematic review, meta-analysis, network meta-analysis, and meta-regression. Surgery for Obesity and Related Diseases 17:6, pages 1206-1217.
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Endre V. NagyPetros PerrosEnrico PapiniMonika KatkoLaszlo Hegedüs. (2021) New Formulations of Levothyroxine in the Treatment of Hypothyroidism: Trick or Treat?. Thyroid 31:2, pages 193-201.
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Navpreet Kaur, Victor G. YoungJr.Jr., Yongchao Su & Raj Suryanarayanan. (2020) Partial Dehydration of Levothyroxine Sodium Pentahydrate in a Drug Product Environment: Structural Insights into Stability. Molecular Pharmaceutics 17:10, pages 3915-3929.
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Connie M. Rhee. (2019) Thyroid disease in end-stage renal disease. Current Opinion in Nephrology and Hypertension 28:6, pages 621-630.
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Bernadette Biondi & David S. Cooper. (2019) Thyroid hormone therapy for hypothyroidism. Endocrine 66:1, pages 18-26.
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Leonidas H. Duntas & Jacqueline Jonklaas. (2019) Levothyroxine Dose Adjustment to Optimise Therapy Throughout a Patient’s Lifetime. Advances in Therapy 36:S2, pages 30-46.
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Carmil Azran, Daniel Porat, Noa Fine-Shamir, Nirvana Hanhan & Arik Dahan. (2019) Oral levothyroxine therapy postbariatric surgery: Biopharmaceutical aspects and clinical effects. Surgery for Obesity and Related Diseases 15:2, pages 333-341.
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Connie M. Rhee, Gregory A. Brent & Kamyar Kalantar-Zadeh. 2019. Endocrine Disorders in Kidney Disease. Endocrine Disorders in Kidney Disease 97 109 .
Connie M. Rhee, Kamyar Kalantar-Zadeh, Vanessa Ravel, Elani Streja, Amy S. You, Steven M. Brunelli, Danh V. Nguyen, Gregory A. Brent & Csaba P. Kovesdy. (2018) Thyroid Status and Death Risk in US Veterans With Chronic Kidney Disease. Mayo Clinic Proceedings 93:5, pages 573-585.
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B. Biondi, L. Bartalena, L. Chiovato, A. Lenzi, S. Mariotti, F. Pacini, A. Pontecorvi, P. Vitti & F. Trimarchi. (2016) Recommendations for treatment of hypothyroidism with levothyroxine and levotriiodothyronine: a 2016 position statement of the Italian Society of Endocrinology and the Italian Thyroid Association. Journal of Endocrinological Investigation 39:12, pages 1465-1474.
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Johannes W. Dietrich, Gabi Landgrafe-Mende, Evelin Wiora, Apostolos Chatzitomaris, Harald H. Klein, John E. M. Midgley & Rudolf Hoermann. (2016) Calculated Parameters of Thyroid Homeostasis: Emerging Tools for Differential Diagnosis and Clinical Research. Frontiers in Endocrinology 7.
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Ruben Vardanyan & Victor Hruby. 2016. Synthesis of Best-Seller Drugs. Synthesis of Best-Seller Drugs 413 418 .
Leonard Wartofsky. 2016. Thyroid Cancer. Thyroid Cancer 427 432 .
Bernadette BiondiLeonard Wartofsky. (2014) Treatment With Thyroid Hormone. Endocrine Reviews 35:3, pages 433-512.
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Andrew Word, Kevin Davidson & Essam Elsayed. (2012) Levothyroxine and Prednisone Causing Generalized Weakness in a Middle-Aged Man. Case Reports in Endocrinology 2012, pages 1-2.
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Dimple Pabla, Fatemeh Akhlaghi & Hossein Zia. (2010) Intestinal permeability enhancement of levothyroxine sodium by straight chain fatty acids studied in MDCK epithelial cell line. European Journal of Pharmaceutical Sciences 40:5, pages 466-472.
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Dimple Pabla, Fatemeh Akhlaghi & Hossein Zia. (2009) A comparative pH-dissolution profile study of selected commercial levothyroxine products using inductively coupled plasma mass spectrometry. European Journal of Pharmaceutics and Biopharmaceutics 72:1, pages 105-110.
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Marisa EisenbergJoseph J. DistefanoIIIIII. (2009) TSH-Based Protocol, Tablet Instability, and Absorption Effects on L-T 4 Bioequivalence . Thyroid 19:2, pages 103-110.
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Mei-Ling Chen & Vincent H.L. Lee. (2008) Equivalence-by-Design: Targeting In Vivo Drug Delivery Profile. Pharmaceutical Research 25:12, pages 2723-2730.
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Guillermo Di Girolamo, Guillermo A. Keller, Antonio R. de los Santos, Daniel Schere & Claudio D. Gonzalez. (2008) Bioequivalence of two levothyroxine tablet formulations without and with mathematical adjustment for basal thyroxine levels in healthy Argentinian volunteers: A single-dose, randomized, open-label, crossover study. Clinical Therapeutics 30:11, pages 2015-2023.
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Kenneth BurmanJames HennesseyMichael McDermottLeonard WartofskyCharles Emerson. (2008) The FDA Revises Requirements for Levothyroxine Products. Thyroid 18:5, pages 487-490.
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Dimple Pabla, Fatemeh Akhlaghi, Aftab Ahmed & Hossein Zia. (2008) Development and validation of an inductively coupled plasma mass spectrometry method for quantification of levothyroxine in dissolution studies. Rapid Communications in Mass Spectrometry 22:7, pages 993-996.
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Thien-Giang Bach-Huynh & Jacqueline Jonklaas. (2006) Thyroid Medications During Pregnancy. Therapeutic Drug Monitoring 28:3, pages 431-441.
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Leonard Wartofsky. 2006. Thyroid Cancer. Thyroid Cancer 293 296 .
Vicky Blakesley, Walid Awni, Charles Locke, Thomas Ludden, G. Richard Granneman & Lewis E. Braverman. (2004) Are Bioequivalence Studies of Levothyroxine Sodium Formulations in Euthyroid Volunteers Reliable?. Thyroid 14:3, pages 191-200.
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